Brain-Computer Interface based on Cortical Electrodes

Completed

Conditions: n.a.
10029317

Registration Number: NL-OMON39771

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

epilepsy patients with implanted electrodes for diagnostic purposes
age 12 years and older (no upper limit)
no metal objects in or around the body (braces, pacemaker, metal fragments) ;(Amendement september 2012): a vagal nerve stimulator is permitted

Exclusion Criteria

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The results are expected to lead up to the development of a first implantable<br /><br>prototype for paralyzed patients. The key questions that will be addressed are:<br /><br>1) which features of brainsignals obtained from cortical surface electrodes can<br /><br>be used for BCI, 2) which brain areas produce the best results for BCI cursor<br /><br>control, 3) can subjects use multiple brain-areas to control a cursor in<br /><br>multiple directions 4) can target areas be pre-localized accurately with fMRI<br /><br>(amendment 12 jan 2012:) 5) are the signals obtained with a prototype<br /><br>implantable amplifier adequate for BCI.<br /><br><br /><br>(amendement september 2012): 2) which brain areas produce the best results for<br /><br>BCI control, 3) can target areas be pre-localized accurately with fMRI, 4) are<br /><br>the signals obtained with a prototype implantable amplifier adequate for BCI.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(amendment 12 jan 2012) A prototype implantable EEG amplifier will be tested<br /><br>outside the body in three patients. The outcome measure is quality of the EEG<br /><br>signal (signal-to-noise ratio) and actual BCI performance with that signal, as<br /><br>compared to those measure obtained with the clinical EEG system (measurements<br /><br>are performed in parallel)<br /><br><br /><br>(amendment september 2012) A prototype implantable EEG amplifier will be tested<br /><br>outside the body. The outcome measure is quality of the EEG signal<br /><br>(signal-to-noise ratio) and actual BCI performance with that signal, as<br /><br>compared to those measure obtained with the clinical EEG system (measurements<br /><br>are performed in parallel). In addition, we would like to determine the optimal<br /><br>settings of the device for accurate BCI control.</p><br>